PROVENCE TWO WAY PACT SPF50PLUS PA PLUS PLUS PLUS 02 NATURAL BEIGE- titanium dioxide, octinoxate, zinc oxide powder

PROVENCE TWO WAY PACT by

Drug Labeling and Warnings

PROVENCE TWO WAY PACT by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Titanium Dioxide 11.64%, Ethylhexyl Methoxycinnamate 6%, Zinc Oxide 2.94%

INACTIVE INGREDIENT

Inactive Ingredients:
Talc, Synthetic Fluorphlogopite, Mica (CI 77019), Barium Sulfate, Silica, Dimethicone, Boron Nitride, Alumina, HDI/Trimethylol Hexyllactone Crosspolymer, Iron Oxides (CI 77492), Methicone, Magnesium Myristate, Methyl Methacrylate Crosspolymer, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Ethylhexylglycerin, Glyceryl Caprylate, Iron Oxides (CI 77491), Fragrance(Parfum), Iron Oxides (CI 77499), Acrylates/Tridecyl Acrylate/Triethoxysilylpropyl Methacrylate/Dimethicone Methacrylate Copolymer, Triethoxycaprylylsilane, Rosmarinus Officinalis (Rosemary) Leaf Extract, Rosa Canina Fruit Oil

PURPOSE

PURPOSE: Sunscreen

WARNINGS

Cautions:
For external use only.
Avoid contact with eyes and mouth.
Discontinue use if signs of irritation or rashes appear.
Keep out of reach of children.
Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

How to Use: Apply an appropriate amount to the skin evenly.

DOSAGE AND ADMINISTRATION

How to Use: Apply an appropriate amount to the skin evenly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE TWO WAY PACT  SPF50PLUS PA PLUS PLUS PLUS 02 NATURAL BEIGE
titanium dioxide, octinoxate, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.39 g  in 12 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.72 g  in 12 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.35 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
Dimethicone (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-207-01	12 g in 1 CARTON; Type 0: Not a Combination Product	02/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2013

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(51346-207)